Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LYY 2022-07-14

Examination gloves-Type A(Latex gloves)

Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K-Number K214017

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OLO 2022-07-14

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Applicant Remex Medical Corporation

K-Number K220348

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QNV 2022-07-14

AHI System

Applicant Fifth Eye, Inc.

K-Number K221203

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NHA 2022-07-14

TruAbutment DS, TruBase

Applicant Truabutment, Inc.

K-Number K213961

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HCG 2022-07-14

CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

Applicant Medos International SARL

K-Number K220040

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OLO 2022-07-14

E-GPS Navigated Instruments

Applicant Precision Spine, Inc.

K-Number K220862

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KGN 2022-07-14

PELNAC Meshed Bilayer Wound Matrix

Applicant Gunze Limited

K-Number K213498

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IRP 2022-07-14

Normatec Go

Applicant NormaTec Industries, LP

K-Number K221666

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NXC 2022-07-14

SmileSeries

Applicant Ordont Orthodontic Laboratories, Inc.

K-Number K221097

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DZE 2022-07-13

SNUCONE Bone Level Implant System

Applicant Snucone Co., Ltd.

K-Number K210354

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GEI 2022-07-13

truSculpt iD

Applicant Cutera, Inc.

K-Number K221407

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MQB 2022-07-13

17HQ701G-B

Applicant Lg Electronics.Inc

K-Number K221434

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